New radiation technique aims to zap prostate cancer with fewer side effects
NCT ID NCT07219303
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new type of radiation therapy called adaptive SBRT for men with intermediate- or favorable high-risk prostate cancer. The goal is to see if it can safely deliver a higher dose of radiation directly to the tumor while avoiding nearby organs, which may reduce side effects. About 80 adults will receive 5 treatments over 2-3 weeks and be followed for up to 5 years to check for side effects and cancer control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Nov 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects must have histologically confirmed intermediate- and favorable high risk (AJCC 8th ed stage IIA-IIC) adenocarcinoma of the prostate. 2. Age \> 18 years. 3. ECOG performance status ≤ 2 4. Prostate volume (segmented) ≤ 100 cc determined by MRI and/or US within 24 mo of treatment for patients not on ADT and within 6 mo for patients on prior ADT. A simulation MRI is acceptable. 5. Subjects must have had a pre-treatment diagnostic multiparametric MRI prostate (mpMRI) showing a PI-RADS3, 4 or 5 lesion or a 68Ga- or 18F-PSMA (TLX591-CDx or piflufolastat F18) PET/CT within 12 mo of study registration. 6. Baseline International Prostate Symptom Score (IPSS) is ≤ 15. Baseline alpha blocker use is allowed. 7. Subjects must have full capacity to understand and be willing to sign the informed consent document. Exclusion Criteria: 1. Subjects must not be experiencing toxicity CTCAE grade ≥ 3 GU or GI toxicity at baseline. 2. Subjects must not be receiving any other investigational agents. 3. Subjects must not have had prior pelvic radiation therapy. 4. Subjects must not have node-positive disease. 5. Subjects must not have extraprostatic extension determined by MRI prostate within 24 mo of treatment. For patients receiving ADT, the prostate MRI must have been obtained prior to the start of ADT. 6. Subjects must not have had prior ablative therapies for prostate cancer including cryosurgery, HIFU and nanoknife. 7. Subjects with prior TURP or laser enucleation are eligible. However, patients that have undergone prior simple prostatectomy are excluded. 8. Subjects that are receiving other antineoplastic agents including methotrexate are ineligible. Subjects that have received prior ADT are eligible if they have received \< 6 mo total of ADT, if last administration of ADT was \> 6 mo prior to registration and serum total testosterone levels have recovered to at least 100 ng/dL. Subjects with prior cancer diagnoses are eligible provided that treatment was completed and no evidence of disease status achieved at least 2 years prior to study registration. 9. Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 10. Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s). 11. Subjects with active inflammatory bowel disease or active collagen vascular disorder. 12. Subjects that cannot undergo prostate fiducial placement. 13. Subjects that cannot undergo rectal spacer placement are excluded. Please, note that a rectal spacer incorporating iodine or similar CT contrast is preferred. However, patients that are able to only have a non-contrast rectal spacer due to iodine allergy or similar contraindication remain eligible. 14. Subjects that cannot undergo prostate MRI. 15. Subjects with bilateral prosthetic hips will be excluded. Subjects with unilateral prosthetic hips will be eligible only if the initial treatment plan meets all target and normal tissue constraints without protocol violation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fox Chase Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19111, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a special PET scan change the course of prostate cancer?
- Hidden bacteria in prostate tumors may shape how the immune system fights cancer
- Prostate tumors hide a Nerve-Fueled neighborhood, and scientists are mapping it
- A proactive care plan may help men with prostate cancer live better